Zenith Alpha G38190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002381909), received between Mar 8, 2017 and Mar 6, 2023 — classified as 4 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (P140016); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  PER THE MEDWATCH REPORT MW5117719 RECEIVED ON (B)(6) 2023: UPON INTRODUCING COOK ZENITH APHA DEVICE FOR POSITIONING AND DEPLOYMENT, THE OUTER SHEATH BROKE OFF AND SEPARATED FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483998 ↗
• InjuryMar 9, 2021Malposition of Device; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TEVAR PROXIMAL TO PREVIOUS TEVAR (B)(6) 2020, ZTA-PT-38-34-217-W, LANDED AT LSA; LSA LCC BYPASS WITH LCC VBX SNORKEL TO ALLOW EXTENSION TO DISTAL EDGE OF INNOMINATE OSTIUM. DURING DEPLOYMENT THE ALPHA GRAFT JUMPED APPROX 3 CM RETROGRADE TO COVER THE INNOMINATE ARTERY (B)(4). AS A RESULT, THE DOCTOR CUT DOWN ON THE RIGHT AXILLARY ARTERY, CANNULATED AND DEPLOYED A GORE VBX IN THE INNOMINATE ARTERY PAST THE PROXIMAL EDGE OF THE ALPHA GRAFT INTO THE ASCENDING AORTA. PATIENT SUBMITTED TO THE HOSPITAL TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W) (B)(4). THE DOCTOR CALLED ME (B)(6) 2020, WITH A PLAN TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. HE INDICATED THAT HE BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX SNORKEL THROUGH THE LCC VIA THE LEFT ARM SO HE COULD EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND HE POSITIONED A ZTA-P-38-167-W4), OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED DEPLOYMENT OF THE GRAFT AFTER AORTOGRAM AND MARKING OF LANDMARKS. TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11446835 ↗
• InjuryFeb 22, 2021Entrapment of Device; Off-Label Use; Malposition of Device; Entrapment of Device; Off-Label Use; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TEVAR PROXIMAL TO PREVIOUS TEVAR ((B)(6) 2020, ZTA-PT-38-34-217-W, LANDED AT LSA); LSA/LCC BYPASS WITH LCC (VBX SNORKEL) TO ALLOW EXTENSION TO DISTAL EDGE OF INNOMINATE OSTIUM. DURING DEPLOYMENT THE ALPHA GRAFT JUMPED APPROX 3 CM RETROGRADE TO COVER THE INNOMINATE ARTERY (PR315664). AS A RESULT, THE DOCTOR CUT DOWN ON THE RIGHT AXILLARY ARTERY, CANNULATED AND DEPLOYED A GORE/VBX IN THE INNOMINATE ARTERY PAST THE PROXIMAL EDGE OF THE ALPHA GRAFT INTO THE ASCENDING AORTA. PATIENT SUBMITTED TO THE HOSPITAL TUESDAY (B)(6) 2020, WITH CHEST PAIN FOLLOWING A TEVAR ON (B)(6) 2020. CT REVEALED POSSIBLE TYPE 1A ENDOLEAK AT THE LSA (PROX EDGE OF INITIAL GRAFT ZTA-PT-38-34-217-W) (PR321126). THE DOCTOR CALLED ME 25NOV2020 WITH A PLAN TO EXTEND PROXIMALLY WITH A SHORT 36 OR 38MM ALPHA. HE INDICATED THAT HE BEGIN WITH LSA/LCC BYPASS ALONG WITH A VBX ¿SNORKEL¿ THROUGH THE LCC VIA THE LEFT ARM SO HE COULD EXTEND THE PROXIMAL EDGE OF THE GRAFT OVER THE LCC TO THE INNOMINATE. THIS PLAN WAS PUT INTO EFFECT AND HE POSITIONED A ZTA-P-38-167-W OVER A 300 COUBLE CURVED LUNDERQUIST AND INITIATED DEPLOYMENT OF THE GRAFT AFTER AORTOGRAM AND MARKING OF LAND

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11356921 ↗
• DeathOct 19, 2020Malposition of Device; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT WAS DECEASED. THE PATIENT CAME BACK A MONTH LATER WITH AN ASCENDING DISSECTION THAT WASN¿T THERE ON HER POST OP DAY 2 CTA. SO IT WASN¿T DIRECTLY RELATED TO THE DEVICE IN THAT IT HAPPENED IMMEDIATELY BUT OBVIOUSLY THE GRAFT AND TEVAR MOST LIKELY PLAYED A PART. ¿ (PR306148). ADDITIONAL INFORMATION RECEIVED 06AUG2020: "I MEAN TO SAY I THINK IT'S SURGERY RELATED BUT I DON'T THINK IT HAS TO DO WITH THE COOK DEVICE ITSELF. I DON'T THINK IF I HAD USED ANOTHER VENDOR THERE'D BE A DIFFERENT OUTCOME IF THAT MAKES SENSE." ADDITIONAL INFORMATION RECEIVED ON 23SEP2020: AN IMAGING REVIEW PERFORMED IN PR306148 REVEALED THE FOLLOWING: THE LEFT SUBCLAVIAN ARTERY (LSA) WAS NOT OCCLUDED DESPITE AN AMPLATZER PLUG. AS A RESULT, A LARGE TYPE IA ENDOLEAK PERFUSED THE FALSE LUMEN THROUGH THE SMA OSTIUM. FILLING OF AN UNUSUAL BRONCHIOLE ARTERY AT THE SEALING STENT IS FURTHER EVIDENCE OF THE TYPE IA ENDOLEAK. (PR310104). PATIENT OUTCOME: PATIENT EXPIRED (B)(6) 2020.

  Patient problems: Death; No Code Available

  MAUDE report 10700370 ↗
• DeathOct 5, 2020Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT WAS DECEASED. THE PATIENT CAME BACK A MONTH LATER WITH AN ASCENDING DISSECTION THAT WASN¿T THERE ON HER POST OP DAY 2 CTA. SO IT WASN¿T DIRECTLY RELATED TO THE DEVICE IN THAT IT HAPPENED IMMEDIATELY BUT OBVIOUSLY THE GRAFT AND TEVAR MOST LIKELY PLAYED A PART. ¿ (B)(4) ADDITIONAL INFORMATION RECEIVED 06AUG2020: "I MEAN TO SAY I THINK IT'S SURGERY RELATED BUT I DON'T THINK IT HAS TO DO WITH THE COOK DEVICE ITSELF. I DON'T THINK IF I HAD USED ANOTHER VENDOR THERE'D BE A DIFFERENT OUTCOME IF THAT MAKES SENSE." ADDITIONAL INFORMATION RECEIVED ON 23SEP2020: AN IMAGING REVIEW PERFORMED IN (B)(4) REVEALED THE FOLLOWING: THE LEFT SUBCLAVIAN ARTERY (LSA) WAS NOT OCCLUDED DESPITE AN AMPLATZER PLUG. AS A RESULT, A LARGE TYPE IA ENDOLEAK PERFUSED THE FALSE LUMEN THROUGH THE SMA OSTIUM. FILLING OF AN UNUSUAL BRONCHIOLE ARTERY AT THE SEALING STENT IS FURTHER EVIDENCE OF THE TYPE IA ENDOLEAK. (B)(4) PATIENT OUTCOME: PATIENT EXPIRED (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Death; No Code Available

  MAUDE report 10626045 ↗
• DeathAug 18, 2020Entrapment of Device; Entrapment of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFORMATION RECEIVED 03AUG2020 INDICATED PATIENT WAS DECEASED. 03AUG2020, THE DM WAS REQUESTED TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN TO KNOW IF THE PHYSICIAN FEELS OUR DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. 06AUG2020, THE DM RESPONDED WITH INFORMATION FROM THE PHYSICIAN INDICATING ¿I DON¿T KNOW HONESTLY BUT PROBABLY. SHE CAME BACK A MONTH LATER WITH AN ASCENDING DISSECTION THAT WASN¿T THERE ON HER POST OP DAY 2 CTA. SO IT WASN¿T DIRECTLY RELATED TO THE DEVICE IN THAT IT HAPPENED IMMEDIATELY BUT OBVIOUSLY THE GRAFT AND TEVAR MOST LIKELY PLAYED A PART. ¿ ADDITIONAL INFORMATION RECEIVED 06AUG2020 FROM THE PHYSICIAN: "I MEAN TO SAY I THINK IT'S SURGERY RELATED BUT I DON'T THINK IT HAS TO DO WITH THE COOK DEVICE ITSELF. I DON'T THINK IF I HAD USED ANOTHER VENDOR THERE'D BE A DIFFERENT OUTCOME IF THAT MAKES SENSE." PATIENT OUTCOME: DEATH.

  Patient problems: Death; Vascular Dissection

  MAUDE report 10420999 ↗
• DeathAug 17, 2020Entrapment of Device; Off-Label Use; Entrapment of Device; Off-Label Use

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Death; Vascular Dissection

  MAUDE report 10412392 ↗
• MalfunctionMar 8, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEVICE WOULD NOT DEPLOY AND THE SHEATH ELONGATED AND STRETCHED. THE PHYSICIAN ABORTED UTILIZING THE DEVICE AND USED A COMPETITORS TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6386531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140016. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2026 · Sep 18, 2025 · Open, Classified
  Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W
• Z-2099-2017 · Mar 22, 2017 · Terminated
  Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descend