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

Catalog Number	1235300-28
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient codes: (b)(4) labeled 2100 labeled device codes: (b)(4) labeled na internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 treatment appears to be related to the circumstances of the procedure.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The additional absorb gt1 referenced in b5 and d11 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2016 one 3.0x28 and one 3.0x23 absorb gt1 scaffold were implanted in the heavily calcified, mid to distal left anterior descending coronary artery.The patient had chest pain on (b)(6) 2016 and was found to have in-scaffold thrombosis in both scaffolds.The thrombus was treated with balloon dilatation using a non-compliant balloon.The patient had a good outcome.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: 6100329
• Report Number: 2024168-2016-07933
• Device Sequence Number: 11054767
• Product Code: PNY
• UDI-Device Identifier: 08717648213069
• UDI-Public: (01)08717648213069(17)170711(10)6071261
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/14/2016

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: 07/11/2017
• Device Catalogue Number: 1235300-28
• Device Lot Number: 6071261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTHER: 3.0 X 23 ABSORB GT1 SCAFFOLD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention