MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235350-28
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation (2001)
Date of Event	07/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.The reported patient effects of cardiac arrest and perforation, as listed in the absorb gt1, electronic instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the ifu states: the absorb gt1 bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat a saphenous vein graft.A 3.5 x 28 mm absorb gt1 scaffold was deployed at 14 atmospheres; however, angiography revealed a perforation.Two graftmaster covered stents (3.5 x 18 mm and 3.5 x 26 mm) were successfully used to seal the perforation.The patient had to have blood transfusions, received cardiopulmonary resuscitation (cpr) and was put on an intra-aortic balloon pump.There was a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5857065
• Report Number: 2024168-2016-05258
• Device Sequence Number: 10973280
• Product Code: PNY
• UDI-Device Identifier: 08717648213144
• UDI-Public: (01)08717648213144(17)170518(10)6051961
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2017
• Device Catalogue Number: 1235350-28
• Device Lot Number: 6051961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 85