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

Catalog Number	1235300-12
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Perforation (2001)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: dilatation catheter: nc sprinter 3.5 x 9 mm; guide wire: prowater.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported scaffold malapposition and patient effects.The reported patient effects of angina and perforation, 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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the 3.0x12 absorb gt1 scaffold was deployed at 14 atmospheres in the mid left anterior descending coronary artery (lad).A waist was noted in the midportion of the gt1 treated with post dilatation with a 3.5x9 mm non-abbott balloon dilatation catheter.This resulted in pericardial staining, consistent with a vessel perforation in the mid lad.The patient had chest discomfort and st depression.A 3.5x15mm graftmaster covered stent was placed across the lesion, deployed at 16 atm with good result.The chest discomfort and st depression resolved after the perforation was sealed with the graftmaster.No further staining was noted and the patients blood pressure remained stable.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: 6124348
• Report Number: 2024168-2016-08256
• Device Sequence Number: 710755
• Product Code: PNY
• UDI-Device Identifier: 08717648213021
• UDI-Public: (01)08717648213021(17)170406(10)6040761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2017
• Device Catalogue Number: 1235300-12
• Device Lot Number: 6040761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 11/23/2016
• 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: CONCOMITANT MEDICAL DEVICES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 58