Absolute Pro 1012536-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648176173), received between Dec 8, 2016 and Aug 19, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Entrapment of Device; Mechanical Jam; Activation Failure

  It was reported that the procedure was to treat a moderately calcified left superficial femoral artery lesion. An 8x100 mm Absolute Pro self-expanding stent was advanced. During deployment, resistance was noted with deployment mechanism "[thumbwheel]". The stent was deployed 20mm and became stuck. Surgery was performed to remove the stent and complete the procedure. There were no adverse patient effects and there was no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331453 ↗
• MalfunctionJun 23, 2026Activation Failure

  IT WAS REPORTED THAT THE 8.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) DID NOT DEPLOY CORRECTLY AND WAS REMOVED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597359 ↗
• MalfunctionJan 12, 2026Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 8X100MM ABS PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION, AND THE STENT WAS BEING RELEASED AND BEGAN TO FLOWER WHEN THE THUMBWHEEL WAS NOTED TO BE STIFF. HOWEVER, THE STENT WAS ULTIMATELY ABLE TO BE FULLY RELEASED AND IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040463 ↗
• MalfunctionNov 25, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION. THE 8X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE WHEEL WAS ATTEMPTED TO BE TURNED BUT WAS STUCK. THE STENT COULD NOT BE DEPLOYED AND WAS NOT EXPOSED OR FLOWERED. A NEW ABSOLUTE PRO SESS WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT SHEATH WAS SEPARATED AND THE STENT WAS DEPLOYED AND NOT RETURNED. THE STENT WAS DEPLOYED ON THE BACK TABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649301 ↗
• MalfunctionMar 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 8.0X100MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT DID NOT DEPLOY. THE SESS WAS REMOVED WITHOUT ISSUE AND A NEW ABSOLUTE PRO WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE STENT WAS PARTIALLY EXPOSED FROM THE DISTAL END OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630574 ↗
• MalfunctionJan 22, 2025Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ILIAC ARTERY. THE 8X100MM ABSOLUTE PRO SELF EXPANDING STENT (SES) WAS ADVANCED OVER AN UNSPECIFIED 0.014 GUIDE WIRE. THE THUMBWHEEL WAS ENGAGED YET STUCK THUS PREVENTING THE STENT FROM BEING DEPLOYED. A 8X80MM ABSOLUTE PRO SES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS PARTIALLY DEPLOYED/FLOWERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210239 ↗
• InjuryAug 22, 2022Break; Difficult or Delayed Activation; Physical Resistance/Sticking; Break; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE MODERATELY CALCIFIED LESION IN THE LEFT ILIAC ARTERY. THE 8.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE SESS WAS BEING DEPLOYED PER THE IFU; HOWEVER, THE THUMBWHEEL STOPPED WORKING AND THE DEPLOYMENT COULDN¿T CONTINUE. THE HANDLE WAS BROKEN TO FULLY RELEASE AND DEPLOY THE STENT. IT LOOKED LIKE THE END OF THE DEPLOYED STENT WAS PARTIALLY FRACTURED; THEREFORE, A NON-ABBOTT STENT WAS DEPLOYED OVER IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271497 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT EXTERNAL ILIAC ARTERY WITH MILD CALCIFICATION. AN 8.0/100MM/135CM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION WITHOUT ISSUE AND THE STENT SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE SESS, IT WAS NOTED THAT THE SYSTEM WAS STUCK ON THE GUIDE WIRE, SO THE SESS AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT WITHOUT FURTHER ISSUES. THE STENT REMAINED WELL IMPLANTED IN THE INTENDED TARGET. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982351 ↗
• MalfunctionMar 15, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILLIAC WITH HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. AN 8.0 X 100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. DURING DEPLOYMENT, THE STENT JUMPED DISTALLY TO PART OF THE AORTA. THE STENT WAS ABLE TO BE IMPLANTED AT THE LESION AND PARTIALLY IN HEALTHY TISSUE (AORTA). THERE WAS NO ISSUE WITH DEPLOYMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771131 ↗
• MalfunctionJan 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2021, AN ABSOLUTE PRO WAS REMOVED FROM THE PACKAGING WHEN A SEPARATION WAS OBSERVED AT THE GUIDE WIRE EXIT PORT. THE DEVICE WAS SET ASIDE AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374903 ↗
• MalfunctionApr 15, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE 8.0X100MM ABSOLUTE PRO WAS REMOVED FROM PACKAGING WITHOUT ANY ISSUES. IT WAS THEN NOTED THAT THE STENT WAS PARTIALLY DEPLOYED (NOT FLOWERED). THE DEVICE WAS NOT USED. A NEW ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11674386 ↗
• MalfunctionMar 25, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0X40MM ARMADA 35 WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED AS RESISTANCE WAS MET WITH ANATOMY. ANOTHER DIFFERENT SIZE ARMADA WAS USED TO SUCCESSFULLY CROSS THE LESION AND DILATE THE LESION. A 8.0X100MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND ONCE READY TO DEPLOY THE THUMBWHEEL WOULD NOT TURN. THE SESS FAILED TO DEPLOY AND ONCE REMOVED THE PHYSICIAN TRIED TO DEPLOY THE DEVICE, BUT THE THUMBWHEEL WOULD STILL NOT TURN. ANOTHER ABSOLUTE PRO WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571581 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A 8.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDABLE STENT AS WELL AS ANOTHER NON-ABBOTT BALLOON EXPANDABLE COVERED STENT IN THE UPPER RIGHT LEG NEAR ABDOMEN. PATIENT BEGAN TO EXPERIENCE PAIN IN ABDOMEN LATER ON THE SAME DAY. IT WAS NOTED PATIENT HAS BEEN ADMITTED TO THE HOSPITAL EIGHT TIMES EVER SINCE BOTH STENTS WERE IMPLANTED AND HAS BEEN SUFFERING FROM ABDOMINAL PAIN, HYPERTENSION, CHEST PAIN, LEG PAIN ON THE RIGHT LEG AND RECENTLY NECK PAIN. FIRST TIME, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) THEY WERE GIVEN ANTIBIOTICS FOR THEIR APPENDIX; HOWEVER; EVERY OTHER TIME THE ER DOCTORS PRESCRIBED MORPHINE AND TRAMADOL. THE PATIENT TAKES TYLENOL AND MOTRIN FOR THE PAIN AND CLONIDINE FOR HIGH BLOOD PRESSURE. AN ULTRASOUND WAS DONE IN (B)(6) 2020, DUE TO ABDOMINAL PAIN AND NO ISSUE WAS FOUND. DOCTOR IS STILL MONITORING THE PATIENT¿S APPENDIX, BUT THE PATIENT IS NO LONGER HAVING TO TAKE ANTIBIOTICS. PATIENT IS NOT SURE WHAT IS CAUSING THE PAIN AND LAST VISIT TO THE ER WAS IN (B)(6) 2020, BUT PATIENT LEFT BEFORE THEY WERE EXAMINED. NO IMAGING WAS PERFORMED ON THE ABSOLUTE PRO STENT. THERE WAS NO CLINICALLY SIGNIFICANT D

  Patient problems: High Blood Pressure/ Hypertension; Pain

  MAUDE report 10877020 ↗
• MalfunctionAug 25, 2020Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED VIA ANTEGRADE APPROACH IN THE LEFT COMMON FEMORAL ARTERY, TO TREAT A LESION IN THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). LASER ATHERECTOMY WAS PERFORMED. THE ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYMENT WAS INITIATED. IT WAS NOTED THAT THE THUMBWHEEL APPEARED STUCK. THE SYSTEM WAS LOCKED AND UNLOCKED TWICE, THEN THE HANDLE WAS JIGGLED. THE THUMBWHEEL WAS ABLE TO TURN; HOWEVER, RESISTANCE WAS NOTED. THE PHYSICIAN WAS ABLE TO TURN THE THUMBWHEEL WITH DIFFICULTY AND THE STENT WAS ABLE TO BE FULLY DEPLOYED AT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452335 ↗
• InjuryOct 2, 2019Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, WHEN THE DEVICE WAS RECEIVED FOR ANALYSIS, THE HANDLE AND COMPONENTS WERE ALL INTACT. ADDITIONAL FOLLOW-UP WITH THE PHYSICIAN REVEALED THAT HE DOES NOT REMEMBER PULLING THE DEVICE APART. HE LOOKED AT THE PATIENT CHART AND HE SAID THERE WERE NOT ANY NOTES IN THE PATIENT'S CHART AS TO ANY COMPLICATIONS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147360 ↗
• InjuryAug 12, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. AN 8X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) FELT RESISTANCE WITH A NON-ABBOTT 6F GUIDING SHEATH DURING ADVANCEMENT. THEN THE STENT SEPARATED INTO TWO PIECES. THE DELIVERY CATHETER FACED RESISTANCE WITH THE ANATOMY DURING REMOVAL, SO FORCE WAS APPLIED. THE SEPARATED PORTION WAS EMBEDDED INTO THE ARTERY WALL WITH AN UNSPECIFIED BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8886119 ↗
• MalfunctionJan 22, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THERE WAS MULTIPLE SMALL PIECES OF WHITE FOREIGN MATERIAL IN THE STERILE PACKAGING OF A 8.0 X 100 MM ABSOLUTE PRO VASCULAR SELF - EXPANDING STENT SYSTEM (SESS). THERE WAS NO REPORTED DAMAGE TO THE INNER POUCH. THE INCIDENT OCCURRED DURING AN INCOMING INSPECTION OF A CONSIGNMENT RETURN AT THE JAPANESE DISTRIBUTION CENTER. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THE FOREIGN MATERIAL AS PART OF THE INNER POUCH.

  Patient problems: No Patient Involvement

  MAUDE report 8269382 ↗
• MalfunctionDec 28, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A WHITE FOREIGN MATERIAL WAS NOTED INSIDE THE PACKAGE OF AN 8.0 X 40 MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS). THERE WAS NO DAMAGE NOTED IN THE INNER POUCH OR THE DEVICE ITSELF. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8203793 ↗
• MalfunctionNov 6, 2018Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE MILDLY TORTUOUS AND HEAVILY CALCIFIED LEFT EXTERNAL ILIAC ARTERY INTERVENTION, THE 6.0 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERE (ATM). A 7.0 X 100 MM ARMADA 35 BDC WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION, BUT AT THE FIRST INFLATION THE BALLOON RUPTURED AT 7 ATM. DURING DEPLOYMENT OF THE 8.0 X 100 ABSOLUTE PRO STENT, THE THUMBWHEEL WAS DIFFICULT AS IT WOULD STOP INTERMITTENTLY, BUT THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043454 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ILIAC ARTERY WITH HEAVY CALCIFICATION. THE 8.0 X 100 MM ABSOLUTE PRO WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED SUCCESSFULLY. HOWEVER, DURING POST DILATATION WITH A NON-ABBOTT BALLOON A DISSECTION OCCURRED AT THE PROXIMAL END OF THE ABSOLUTE PRO STENT IMPLANT. A NON-ABBOTT COVERED STENT WAS USED TO TREAT THE DISSECTION SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6215806 ↗
• InjuryDec 8, 2016Difficult or Delayed Positioning; Difficult To Position

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION IN THE LEFT COMMON ILIAC ARTERY, A 8.0MMX100MMX135CM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUE TO THE LESION. THE DEVICE WAS UNLOCKED WITHOUT ISSUE. AS THE SHEATH WAS BEING RETRACTED DURING DEPLOYMENT, WITH NO RESISTANCE FELT, THE STENT APPEARED TO BE CONSTRICTED AS IT WAS BEING RELEASED AND IT WAS SLOW TO EXPAND. THE STENT WAS ULTIMATELY ABLE TO BE DEPLOYED IN THE TARGET LESION, BUT A WAIST WAS NOTED IN THE STENT. POST-DILATATION WAS PERFORMED BUT THE WAIST WAS STILL PRESENT. THUS, A 7.0MMX59MMX135CM OMNILINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED TO THE ABSOLUTE PRO, BUT THE OMNILINK ELITE WAS UNABLE TO CROSS THROUGH THE WAIST AREA OF THE DEPLOYED ABSOLUTE PRO TO TREAT THE WAIST. THE OMNILINK ELITE STENT WAS ALTERNATIVELY DEPLOYED, OVERLAPPING THE PROXIMAL END OF THE ABSOLUTE PRO STENT. ANOTHER SAME SIZE OMNILINK ELITE STENT WAS THEN ADVANCED AND CROSSED THE ABSOLUTE PRO WITHOUT DIFFICULTY AND WAS DEPLOYED, SUCCESSFULLY RESOLVING THE WAIST, BUT A PERFORATION RESULTED. THE PATIENT BECAME HYPOTENSIVE WHICH WAS RESOLVED WITH MEDICATION. A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156481 ↗